(222 days)
Not Found
No
The device description details a chromatographic immunoassay, which is a chemical reaction-based test. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is an in vitro diagnostic (IVD) assay designed for qualitative screening of drugs in human urine, providing preliminary results for diagnostic purposes. It does not provide any therapeutic benefit to the patient.
Yes
The device is described as an "assay" that provides "qualitative screening results" for various drugs in human urine, and is explicitly stated "For In Vitro Diagnostic Use." This aligns with the definition of a diagnostic device, as it is used to identify the presence of specific substances (drugs or their metabolites) in a sample, which can then be used to inform clinical decisions.
No
The device description clearly outlines a physical chromatographic absorbent device that utilizes chemical reactions and visual color bands to provide results. There is no mention of any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Nature of the Test: The device is designed to test human urine samples in vitro (outside of the body) to detect the presence of specific drugs or their metabolites. This is the fundamental definition of an in vitro diagnostic test.
- Professional Use in Central Laboratories: The intended use specifies professional use in central laboratories, which is a common setting for IVD testing.
- Qualitative Screening Results: The device provides qualitative screening results, which is a type of result commonly obtained from IVD tests.
N/A
Intended Use / Indications for Use
The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine and Phencyclidine in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatogrphy/mass spectrometry (GC/MS) is the preferred confirmatory method.
Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezovlecgonine (BEG/COC), 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DKZ, DJC, DPK, LDJ, LCM
Device Description
New Bay For Sure One Step single and Multiple Drug Screen Test card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibodyantigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine 25 ng/ml of Phencyclidine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
None
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use in central laboratories only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
March 30th, 2005 SECTION II 510(k) SUMMARY
APR 2 4 2006
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
052520 510{k) Number:
Submitter:
Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516
Contact Person:
Rodrigo Berlie New Product Development Director Telephone: (760) 602-2929 Facsimile: (760) 602-2999
Preparation Date:
May 30, 2005
Device Information:
Device Classification Name: Immunoassay, Amphetamine, Methamphetamine, Benzoylecgonine, 11-nor-A-9-THC-9-COOH , Morphine, Phencyclidine. Common/Usual Name: Immunoassay Test System for detection of Multiple Drug (up to 6) Screen Test Device in Human Urine Proprietary Name: Rapid Forsure One Step Multiple Drug ( up tp 6 ) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC, Morphine and Phencyclifice Test
Regulation Number: 21 CFR§862.3650 Regulatory Name: Amphetamine, Methamphetamine, Benzoylecgonine, THC Morphine and Phencyclidine test system Product Code: DJG Regulatory Class: Class II
1
Predicate Devices:
Rapid One Step Strip Buprenorphine Test is substantially equivalent to Monitect Multiple Drug Screen MOR2000/MET/THC/COC/PCP of Branan Medical Corporation, cleared by FDA( K004034), and GC/MS for its stated intended use.
Device Description:
New Bay For Sure One Step single and Multiple Drug Screen Test card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibodyantigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine 25 ng/ml of Phencyclidine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Intended Use:
The Forsure One step single and Multiple Drug screen Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine and Phencyclidine Cassette Test are a Chromatographic immunoassay for qualitative determination of the presence of Amphetamine at a cutoff concentration of 1000 ng/ml, Methamphetamine at a cutoff concentration of 1000 ng/ml, THC at a cutoff concentration of 50 ng/ml, Morphine at a cutoff concentration of 2000 ng/ml, Benzoylecgonine at a cutoff concentration of 300 ng/ml , Phencyclidine at a cutoff concentration of 25 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine and Phencyclidine in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatogrphy/mass spectrometry (GC/MS) is the preferred confirmatory method.
2
Comparison to Predicate Device(s):
Forsure Multiple Rapid One Step Drug Screen Test is substantially equivalent to Branan's Monitect Drug Screen Cassette Test system cleared by FDA, e.g., the Brana's Monitect Assay (004034 )and GC/MS for its stated intended use.
| Device Characteristics | Subject Device | Predicate Devicce(s) |
|---|---|---|
| Intended Use | Forsure Multiple Drug Screen one | |
| step Immunochromatographic | ||
| Qualitative test. | ||
| The assay provides a simple and | ||
| rapid analytical screening | ||
| procedure to detect up to six | ||
| different abuse drug | ||
| (Amphetamine,Methamphetamine, | ||
| Benzoylegconine, THC, | ||
| Morphine,and Phencyclidine) in | ||
| human urine | Monitect Drug Screen | |
| Cassette Assay ( K004034) | ||
| and GC/MS | ||
| Monitect Multiple Drug | ||
| Screen | ||
| immunochromatographic | ||
| assay for qualitative | ||
| determination of the | ||
| presence of up to five | ||
| different drug | ||
| (Amphetamine, | ||
| Methamphetamine, THC, | ||
| Benzoylecgonine, | ||
| Phencyclidine in human | ||
| urine. | ||
| Analyte | ||
| Cutoff | Amp,Mamp,BEG,THC,MOR,PCP | |
| Amp;1000 ng/ml, | ||
| Mamp:1000 ng/ml, | ||
| BEG :300 ng/ml, | ||
| THC: 50 ng/ml. | ||
| MOR; 2000 ng/ml. | ||
| PCP :25 ng/ml. | AMP,Mamp,BEG,THC,PCP | |
| Amp: 1000 ng/ml, | ||
| Mamp;1000ng/ml | ||
| BEG; 300 ng/ml | ||
| THC ; 50 ng/ml | ||
| PCP ; 25 ng/ml | ||
| Matrix | Urine | Urine |
| Calibrator | None | None |
| Instrument | None, Visual read single use | None, Visual Read single |
| use | ||
| Calibration of Reagent | None | None |
| Storage | Below 28 °C until expiration | 15°C - 30°C until expiration |
| date |
Summary:
The information provided in this pre-market notification demonstrates that Forsure Rapid One Step Multiple up to six Drug Screen Test Device is substantially equivalent to Branan's Monitect Drug Screen Cassette Test system and GC/MS.
Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supplied in this pre-market notification provides reasonable assurance that the Forsure Multiple Rapid One Step Drug Screen Test is safe and effective for its stated interded use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized emblem with three curved lines, resembling a person embracing another. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tianjin New Bay Bioresearch Co., Ltd. c/o Mr. Rodrigo Berlic New Product Development Director Aventir Biotech, LLC. 3108 Avenida Olmeda Carlsbad, CA 92009
APR 2 4 2006
Re: K052520
Trade/Device Name: Forsure One Step Multiple (Up to Six) Drug Screen Test Card for Amphetamine, Methamphetamine, Bezoylecgonine, 11-nor-A-9 Tetrahydrocannabinal-9-carboxylic acid, Morphine and Phencyclidine. Regulation Number: 21 CFR8862.3100 Regulation Namc: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DJC, DJC, DPK, LDJ, LCM Dated: April 18, 2006 Received: April 19, 2006
Dear Mr. Berlie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 --
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K052520
Device Name:
Forsure One Step Multiple (Up to Six) Drug Screen Test Card for Amphetamine, Methamphetamine, Bezoylecgonine, 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid, Morphine and Phencyclidine.
Indications for Use:
Forsure One Step Multiple (Up to Six) Drug Screen Test Card is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Bezovlecgonine (BEG/COC), 11-nor-Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THC), Morphine (MOR/OPI) and Phencyclidine (PCP) in human urine at cut off concentrations of AMP 1000 ng/ml, MET 1000 ng/ml, BEG 300 ng/ml, THC 50ng/ml, MOR 2000 ng/ml and PCP 25ng/ml. The device may include as few as one and as many as six individual assays. For In Vitro Diagnostic Use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C.C.
Sign-Off
Diagnostic
Evaluation and Safety
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